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R&D in drugs is in freefall --- more complex science, trials and lack of growing returns has triggered a strong decline in R&D productivity.

Shepherd 18 – Professor of Law, Emory University School of Law. Joanna Shepherd teaches Analytical Methods for Lawyers, Law and Economics, torts, judicial behavior, and legal and economic issues in health policy.

Joanna Shepherd, August 28 2018, “CONSOLIDATION AND INNOVATION IN THE PHARMACEUTICAL INDUSTRY: THE ROLE OF MERGERS AND ACQUISITIONS IN THE CURRENT INNOVATION ECOSYSTEM,” Journal of Healthcare Law and Policy, https://digitalcommons.law.umaryland.edu/cgi/viewcontent.cgi?article=1356&context=jhclp

The number of regulatory requirements imposed by the FDA has increased by 15 percent since the early 2000s.112 The average number of patients required for clinical trials have increased,113 the costs of recruiting patients has increased, the clinical trial period has lengthened, and the number and complexity of clinical tests used in clinical trials have increased.114 The more stringent requirements, along with the more complex science associated with specialized medications, have significantly increased the costs of drug development and FDA approval. Meanwhile, the returns from R&D have not increased to offset the increasing R&D costs. Although drug approval rates vary year-by-year, there has been no consistent increase in FDA approvals in recent decades. 115 Moreover, revenues from new drug sales have steadily declined;116 the average lifetime revenue for new drugs is lower now than at any point in the last 25 years.117 Thus, stagnating or falling returns combined with increasing R&D costs have led to a steady decline in internal R&D productivity.

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